Abstract：Objective To establish a method to determine the related substance in Rivaroxaban.Methods HPLC method was used,column was Diamonsil C8 (250 mm×4.6 mm,5 μm),the mobile phase A was treated with 5 mmol/L ammonium acetate solution (containing 0.3% 25% tetramethyl ammonium hydroxide solution,adjusted to pH 4.8 with glacial acetic acid)-acetonitrile (80∶20),the mobile phase B was treated with 5 mmol/L ammonium acetate solution (containing 0.3% 25% tetramethyl ammonium hydroxide solution,pH was adjusted to 4.8 with glacial acetic acid)-acetonitrile (10:90),which was used as gradient elution The detection wavelength was 250 nm.Results The resolution of rivaroxaban and its related substance was above 2.0,detection limit was 0.2-0.5 ng,quantification limit was 1.0-2.0 ng.Conclusion The method is suitable for the determination of related substance in Rivaroxaban.
黄艳, 陈雪云, 杨雪峰, 刘侠. 高效液相色谱法测定利伐沙班中的有关物质[J]. 中国当代医药, 2017, 24(24): 78-81.
HUANG Yan, CHEN Xue-yun, YANG Xue-feng, LIU Xia. Determination of related substances in Rivaroxaban by HPLC. 中国当代医药, 2017, 24(24): 78-81.
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